Posted by Michael Wonder on 16 Dec 2020
Spark Biomedical receives FDA breakthrough device designation for infant transcutaneous auricular neurostimulation device, the Roo system
15 December 2020 - Breakthrough designation helps advance the therapy targeting a significant unmet need in the treatment of neonatal opioid withdrawal syndrome.
Spark Biomedical announced today that the U.S. FDA granted breakthrough device designation to the Roo System: a transcutaneous electrical nerve stimulator that aids in the reduction of signs and symptoms of neonatal opioid withdrawal syndrome.
The Roo system is a non-invasive neurostimulation device based on the company’s adult device, the Sparrow therapy system.
